Using CHWs or Mailing Self Sampling Home Tests to Increase Cervical Cancer Screening in South Florida

Not Applicable

Completed

• Conditions: Cervical Cancer
• Interventions: Behavioral: CHW and Self-sampling for Cervical Cancer; Behavioral: Mailed Self Sampler

• Registration Number: NCT02202109
• Lead Sponsor: University of Miami

Brief Summary

The study will test the significance of community health worker (CHW) participation by comparing self-sampling provided by a community health worker and self-sampling provided by mail. The study will enroll 700 participants in communities that lack access to medical care in South Florida.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-07-09
• Study First Submitted QC: 2014-07-25
• Study First Posted: 2014-07-28
• Study Start: 2015-01
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Results First Submitted: 2018-07-03
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-13
• Last Update Submitted: 2018-12-13
• Results First Posted: 2018-12-19
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 602

Inclusion Criteria

• Women
• Haitian, Hispanic, or African American
• Ages 30-65 years
• Report not having had a pap smear in the last three years live in the cities of Miami/Little Haiti, Hialeah or unincorporated Southern Miami-Dade

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Exclusion Criteria

• Women who report having had a hysterectomy
• Women who have a history of cervical cancer
• Women who plan to move outside of Miami-Dade county during the next six months
• Women who are enrolled in any other cancer prevention/outreach related study
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CHWs facilitated Self-Sampling	CHW and Self-sampling for Cervical Cancer	CHW and Self-sampling for Cervical Cancer. Home visit, self-sampler, collection of test
Mailed Self-Sampler	Mailed Self Sampler	Mailed Self Sampler. Self sampler is mailed to participant; follow up by phone

Primary Outcome Measures

Name	Time	Method
Number of Participants Completing a Self-sampling Test	2 to 6 months	The primary outcome is having had a self-sampling done since the initial evaluation. Participants who test negative will be encouraged to rescreen while Participants who test positive for HPV will be navigated to appropriate follow-up care. The CHWs will follow up with participants who do not return the kit within 60 days.

Secondary Outcome Measures

Name	Time	Method
Proportion of Change in Cervical Cancer Knowledge Among Participants	Baseline, 6 months	Cervical cancer knowledge was measured with a series of questions asked at both pre(baseline) and post (exit). The questions were designed to measure participant's knowledge of cervical cancer prior to the study intervention and following the intervention. Cervical cancer knowledge is defined by participants answering 3 out 5 questions correctly.
Proportion of Participants With a Change in Access to Care	Baseline, 6 months	Access to care was defined as having a routine source of care and measured at both pre(baseline) and post (exit).

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States